Helena Laboratories, Corp. K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to complaints received associated with cracked/split test tube caps.

Recommended Action

Per FDA guidance

On 11/09/2020, international distributors were initially contacted and provided with a notification for distributors letter. On 11/16/2020 domestic customers were contacted via telephone and then a formal notification was delivered. The Recalling Firm was informing its customers to the potential of defect associated with the (flip-top) caps for some test tubes where the cap my split resulting in leaking of biohazardous fluids as users are instructed to shake the tube for proper mixing. Customers are instructed to immediately examine their inventory and quarantine affected product. If customers have further distributed the affected product, they are asked to identify the users within their facility to notify them at once of this product recall. Customers are also asked to complete and return the response form as soon as possible. For any questions, customer can email or call the Recalling Firm as jhanka@Helena.com or 1-800-231-5663 extension 1177.